Label: BURN N BITE- lidocaine, menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 17, 2022

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  • Drug Facts

  • Active Ingredient

    Lidocaine 2%
    Menthol 1%

  • Purpose

    Ant-itch, Pain Relief

  • Uses

    for the temporary relief of pain and discomfort caused by • minor burns • sunburn • scrapes • insect bites • minor skin irritations • rashes due to poison ivy, oak and sumac.

  • Warnings

    For external use only.

    When using this product

    • Avoid contact with eyes

    Do not use

    • Under bandages or compresses

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days 

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years of age and older: Apply to the affected area not more than two times daily.

    Children under 2 years of age: Do not use, consult a doctor

  • Inactive Ingredients

    Deionized water, propylene glycol, aloe, isopropyl alcohol, carbomer, triethanolamine, phenoxyethanol

  • Questions or comments:

    858-782-6627, 816-421-8081

    Stanmar Laboratories     

    Division of Q.A. Laboratories

    404 Admiral Boulevard Kansas City, MO 64106

    Ideazbrands.com

    Made in the USA

  • Packaging

    BURN N BITEBURN N BITE

  • INGREDIENTS AND APPEARANCE
    BURN N BITE 
    lidocaine, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52099-9005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE (UNII: V5VD430YW9)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52099-9005-1141 g in 1 TUBE; Type 0: Not a Combination Product03/30/1994
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/30/1994
    Labeler - Q.A. Laboratories (065361149)
    Establishment
    NameAddressID/FEIBusiness Operations
    Q.A. Laboratories065361149manufacture(52099-9005)
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